ABThera Clinical Guidelines March 2010

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CONTENTS About the guidelines

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Definitions

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1. The Open Abdomen as a Treatment Option

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Indications for Open Abdomen Principles for Managing the Open Abdomen Total Management of the Open Abdomen

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2. Total Management of the Open Abdomen

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Temporary Abdominal Closure Using ABThera™ Open Abdomen Negative Pressure Therapy System for Active Abdominal Therapy Structural Classification of the Open Abdomen Management According to Grades Initial Application and Dressing Changes Timing of Definitive Closure Discontinuing Therapy

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Wound Preparation ABThera™ Visceral Protective Layer Folding Visceral Protective Layer to Size Cutting Visceral Protective Layer to Size Perforated Foam Application Drape Application Tubing Set/Interface Pad Application Dressing Removal Dressing Changes ABThera™ Open Abdomen Negative Pressure Therapy Unit User Interface 1000 (cc/mL) Canister Preparation for Use Connect Tubing Set/Interface Pad to Canister Open Abdomen Negative Pressure Therapy Unit Placement Beginning Therapy Stopping Therapy/Changing the Canister Care and Cleaning Pressure Settings

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References

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Appendix 1. ABThera™ Open Abdomen Negative Pressure Therapy System Safety Information

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Contact your local KCI representative if you have any questions about operation or use. For further information visit www.kci1.com.

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CAUTION: Federal (USA) law restricts this device to sale/rental by or on the order of a physician.

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3. Application of ABThera™ System for Active Abdominal Therapy

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Always consult sections of this booklet and any other product labeling and instructions before applying KCI systems for active abdominal therapy.

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These guidelines are not intended as a guarantee of results, outcome or performance of the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy. As with any application, please consult the patient’s lead clinician about individual conditions and treatments, and follow all applicable manuals and reference guides as to product use and operation.

KCI USA, Inc. San Antonio, Texas 78219 USA 1-800-275-4524

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ABTHERA™ OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM FOR ACTIVE ABDOMINAL THERAPY INDICATIONS FOR USE n The ABThera™ Open Abdomen Negative Pressure Therapy (NPT) System is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeated abdominal entries are necessary. The intended use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome. n The ABThera™ NPT System is intended for use in the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating room.

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Perforated foam

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Visceral Protective Layer (VPL)

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The ABThera™ Open Abdomen Negative Pressure Therapy System* consists of the following components:

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Tubing set

Negative pressure source

*Check availability of ABThera™ Open Abdomen Negative Pressure Therapy System with your local KCI sales representative.

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ABOUT THE GUIDELINES

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This booklet discusses the clinical value and use of the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy. In particular, it describes the practical application of the ABThera™ NPT System in the management of the open abdomen. The next generation ABThera™ NPT System builds on current expertise and clinical experience with the V.A.C.® Abdominal Dressing System and has been designed to simplify application and enhance removal of exudate.

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Following a preliminary meeting in November 2007, an international consensus group convened in the Netherlands in January 2009 to develop the guideline content using group discussion. In addition, further input was received from specialists in the field unable to attend the consensus group meeting. The recommendations are based on current clinical evidence or, where this is not available, the majority consensus of the international group of experts (see below). The main outcomes from the 2009 meeting include the development of a new classification system, which can be used as a model of care for clinicians who are responsible for managing patients with an open abdomen; and the recognition that although different etiologies present separate challenges, the fundamental principles guiding the strategy for temporary abdominal closure remain similar for all patients. The new classification can be used by clinicians to clarify the position and application of the ABThera™ NPT System at predefined stages. As with any clinical guidance, each patient and circumstance is unique. Individual clinician discretion is advised. INTERNATIONAL CONSENSUS GROUP

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Mr Alastair Windsor (Chair), Consultant Colorectal Surgeon, Department of General Surgery, University College Hospital, London, UK Mr Paul Banwell (Co-Chair), Consultant Plastic and Reconstructive Surgeon, Queen Victoria Hospital, East Grinstead, UK Prof Martin Björck, Professor of Vascular Surgery, Institution of Surgical Sciences, Department of Vascular Surgery, University Hospital, Uppsala, Sweden Dr Andreas Bruhin, General Surgeon, Department of Visceral Surgery and Traumatology, Kantonsspital, Lucerne, Switzerland Prof Martin Büsing, Plastic Surgeon, Miners Hospital, Recklinghausen, Germany Dr Michael Cheatham, Director, Surgical Intensive Care Units, Orlando Regional Medical Center, Florida, USA Dr Subhas Gupta, Chief of Surgical Services, Loma Linda University, USA Dr Mark Kaplan, Chief, Division of Trauma and Surgical Critical Care, Albert Einstein Medical Center, Philadelphia, USA Dr Daniel Hinck, General and Vascular Surgeon, Department of General, Visceral and Vascular Surgery, Itzehoe Hospital, Germany Prof Giuseppe Manca, Professor of Surgery, Department of General and Vascular Surgery, Careggi Hospital, Florence, Italy Assoc Prof Colin Song, Department of Plastic, Reconstructive and Aesthetic Surgery, Singapore General Hospital, Singapore Prof Michael Sugrue, General Surgeon, Letterkenny and Galway University Hospitals, Ireland Dr Thomas Wild, Medical Director, Wound Care Management, Institute of Nursing Science, General Surgeon, Paracelsus Medical University of Salzburg, Austria

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DEFINITIONS

Abdominal Compartment Syndrome (ACS) A sustained increase in the pressure (>20mmHg) within the abdominal compartment (bounded by the abdominal wall, pelvis, diaphragm and retroperitoneum), combined with new organ dysfunction and/or failure1. ACS frequently requires operative decompression when elevated intra-abdominal pressure (IAP) is refractory to non-operative therapeutic interventions2.

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Adherence The term is used to describe a deterioration in the open abdominal wall in which the intraabdominal contents become adherent to the underside of the muscle or fascial edges. This process, unless interrupted, will compromise the surgeon’s ability to achieve fascial closure.

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Damage Control Surgery This involves abbreviated resuscitative surgery and restoration of near normal physiology to control a life-threatening situation. In abdominal trauma it refers principally to the control of bleeding and in abdominal contamination to the control of the source of contamination/infection and peritoneal lavage3,4. This staged approach using an initial abbreviated laparotomy requires temporary abdominal closure (TAC) and resuscitation in the ICU before subsequent definitive repair and abdominal closure. Fixity The term ‘fixity’ is used to describe a rigidity or a loss of compliance of the muscles or fascia of the abdominal wall. Fixity is often associated with a lateralization of the abdominal wall muscles, leading to a wide defect that is difficult to close.

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Functional Abdominal Closure A surgical procedure to close the open abdomen using mesh or other prosthetic materials when delayed primary fascial closure is not possible. The aim is to achieve a successful reconstruction with a fully functional abdominal wall. Intra-Abdominal Hypertension (IAH) A sustained or repeated pathologic elevation in abdominal pressure of IAP ≥12mmHg1.

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Intra-Abdominal Pressure (IAP) This refers to the pressure concealed within the abdominal cavity1. IAP is most commonly measured indirectly via the bladder using the patient’s indwelling urinary catheter. To observe a trend in elevation IAP should be measured several times a day5. Open Abdomen (OA) A technique, also known as laparostomy, in which the fascia is left open intentionally to avoid elevation of IAP and where surgical re-exploration is desirable. TAC is achieved using a dressing or technology intended to protect the exposed viscera. Total Management of the Open Abdomen This refers to an integrated approach in patients who require an open abdomen and TAC that involves: n managing the critically ill patient and preventing further decline and systemic complications n managing the abdominal pathology and preparing the local defect to facilitate definitive closure (the aim of active abdominal therapy) n applying definitive closure techniques that reduce the herniation rate.

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1. THE OPEN ABDOMEN AS A TREATMENT OPTION

INDICATIONS FOR OPEN ABDOMEN In the management of various surgical conditions including peritonitis, intra-abdominal trauma and mesenteric ischemia, early definitive closure of the abdominal wall (i.e. closure of the fascial layer and skin) may place the patient at risk of developing IAH and/or ACS. In these cases, patients are increasingly managed using a damage control approach with abbreviated operating times and a laparostomy to allow subsequent re-exploration or to prevent elevated IAP6.

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Clinical situations in which it is preferable or necessary to manage patients with an open abdomen include: n The septic contaminated abdomen that cannot be closed for infectious reasons (e.g. pancreatitis, necrotising fasciitis, peritonitis) and/or where re-explorations are necessary. n The patient with a tense abdomen after massive resuscitation or a prolonged major surgical procedure, who is at risk of developing ACS. n A ‘damage control’ situation where the patient remains inadequately resuscitated and who needs a period of intensive care therapy prior to a definitive surgical procedure. n The patient with primary or secondary ACS, who needs a life-saving decompressive laparotomy.

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The concept of the open abdomen is not new, although historically it has been associated with significant morbidity and mortality. Over the past two decades, evolving physiological knowledge and intensive care practices, together with the advent of various TAC techniques, including KCI’s open abdomen negative pressure therapy system, have resulted in many centers reporting significant improvements in patient outcomes 7-9. Trauma and sepsis There is some confusion in the literature as to whether management should differ regarding the treatment of patients with trauma versus sepsis as the primary clinical cause of an open abdomen. However, regardless of etiology, the principles of management should be the same. Differences in outcome may reflect the fact that trauma patients tend to be younger, are seen earlier and may recover more quickly from the inflammatory processes associated with the open abdomen. Source control and preservation of viable tissue in these patients is critical. In addition, patients with sepsis have an increased overall rate for small bowel fistula10.

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1. THE OPEN ABDOMEN AS A TREATMENT OPTION

PRINCIPLES FOR MANAGING THE OPEN ABDOMEN The principal goal is to manage the critically ill patient at risk of developing systemic complications by controlling both the abdominal contents and the opening that gives access to the abdominal cavity. The control of intra-abdominal fluid secretion and preservation of the fascia is a major challenge in the management of these patients7. The ultimate goal is to achieve delayed primary fascial closure. On occasion, when the latter is not possible, functional abdominal closure using mesh or other prosthetic materials is reasonable and helps to minimize subsequent herniation.

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Patients with an open abdomen represent a heterogeneous group and are infrequently seen by the majority of surgeons. Involvement of a surgeon with the relevant expertise is essential and prompt advice from a specialist center should be sought.

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A consensus clinical pathway for managing the open abdomen over time using the ABThera™ Open Abdomen Negative Pressure Therapy System9 describes three treatment phases: acute (24 - 72 hours); intermediate (72 hours to 10 days) and late reconstructive (10 days to final closure).

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In the early treatment phase, the initial task is to resuscitate and stabilize the patient using damage control surgery involving an abbreviated laparotomy to control bleeding, IAH and contamination, followed by the application of a system to temporarily close the abdomen. This process helps to begin restoration of normal physiology and source control of infection/peritonitis.

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Once stabilized and in the ICU, the patient, depending on his/her underlying pathology, should undergo core re-warming, correction of coagulopathy, optimization of hemodynamics, ventilatory support and definitive investigation. Back in the operating theater, the dressing is removed and, if the criteria for closure can be met, the abdomen is closed.

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The following criteria can be used by the surgeon at each dressing change when deciding whether to close the abdomen: n IAP <15mmHg. n Fascia can be closed without excessive tension or increase in IAP. n Local infection is treated. n No further surgical interventions are planned. If the abdomen cannot be closed (e.g. due to intestinal edema and/or contamination), ongoing management aims to prevent clinical deterioration with loss of fascial mobility and domain.

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1. THE OPEN ABDOMEN AS A TREATMENT OPTION

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TOTAL MANAGEMENT OF THE OPEN ABDOMEN The international consensus group agreed with the phrase ‘total management of the open abdomen’ to describe an integrated approach involving resuscitation, management and definitive closure in patients who require an open abdomen and TAC. It involves regular evaluation and re-evaluation of the abdominal contents and the wound environment, paying particular attention to: n preserving the fascia and skin n minimizing the fascial defect (lateralization and fixity) n preventing adhesion of the intestines to the bowel wall n preventing associated complications, in particular fistula formation.

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During this process of optimizing the wound environment in preparation for definitive closure, the clinician also needs to concentrate on a number of important related factors, which can be categorized as follows: n Structural – protect the exposed bowel loops – achieve source control (infection/hemorrhage) – prevent or minimize the risk of subsequent complications, such as hernia – minimize abdominal wall expansion (lateralization and fixity). n Physiological – restore/maintain mesenteric circulation – control peritoneal fluid and third-space fluid loss – remove and quantify exudate – remove inflammatory mediators – minimize increase in IAP and risk of ACS – modify the immune response.

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Other practical goals include: facilitate nursing care (e.g. secure dressing, control of exudate, allow for prone ventilation); improve patient comfort; promote ambulation and early enteral feeding to permit early discharge from ICU.

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2. TOTAL MANAGEMENT OF THE OPEN ABDOMEN

TEMPORARY ABDOMINAL CLOSURE All patients with an open abdomen will require TAC to allow for a period of optimization prior to definitive closure. To achieve this balance of delayed primary fascial or functional abdominal closure as well as structural and physiological protection, the clinician needs to utilize a TAC technique that does more than simply contain the abdominal contents (viscera).

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Techniques for TAC are varied and have evolved from basic methods, which can be used to simply contain the visceral contents, to more dynamic modern devices such as the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy, which have a number of advanced wound management functions. In addition to the obvious benefits (e.g. allowing rapid access for re-entry, placement without suturing, containing and protecting the viscera, and providing a barrier to external contaminates), the KCI system is intended to provide active abdominal therapy by controlling the abdominal contents, removing exudate and infectious materials, helping to estimate third space fluid losses, reducing edema, and minimizing fascial retraction and loss of domain.

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STRUCTURAL CLASSIFICATION OF THE OPEN ABDOMEN The following classification scheme was developed during the consensus meetings on the management of the open abdomen using the V.A.C.® Abdominal Dressing System held in November 2007 and January 2009 and is based on previous work by Banwell and Téot15 and Swan and Banwell16 . This new classification system uses grades to describe the natural history of clinical improvement or deterioration in patients with an open abdomen17. Table 2.1: Classification of the open abdomen17 Grade 1a

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Description Clean open abdomen (OA) without adherence and/or fixity

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Contaminated OA without adherence and/or fixity

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Clean OA developing adherence and/or fixity

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Contaminated OA developing adherence and/or fixity

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OA complicated by fistula formation

Complex

Frozen OA with adherent/fixed bowel, unable to close surgically, with or without fistula

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2. TOTAL MANAGEMENT OF THE OPEN ABDOMEN

MANAGEMENT ACCORDING TO GRADES The aim of treatment is to maintain the patient’s open abdomen at the lowest and simplest grade (e.g. with a clean open abdomen without adherences between the viscera and the abdominal wall, without lateralization of the fascia, contamination or fistula formation) and to prevent progression to a more complex grade. This goal is supported by the safe use of the KCI system for active abdominal therapy, together with adequate resources to ensure a successful outcome. Suboptimal treatment may cause adhesions to develop and/or the fascia to become fixed laterally.

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Grade 1a: Clean open abdomen without adherence and/or fixity This situation often occurs following a decompressive laparotomy for ACS, following a ruptured abdominal aortic aneurysm or following abdominal trauma not associated with visceral perforation. Provided the patient does not have other risk factors for poor outcome, the prognosis is good. The primary aim is to maintain the patient as a Grade 1a and to achieve delayed primary fascial closure with the support of a KCI system for active abdominal therapy (e.g. ABThera™ Open Abdomen Negative Pressure Therapy System).

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Grade 1b: Contaminated open abdomen without adherence and/or fixity Typical scenarios include patients with local or generalized perforation due to infection such as diverticulitis, or perforation due to ischemia, anastomotic breakdown after colorectal surgery, or trauma affecting the gastrointestinal tract. The aim is to convert the open abdomen to a clean situation and to prevent fixity or lateralization. In addition, in patients with a Grade 1b open abdomen that is unlikely to close rapidly, mesh, elastic loops or other adjuncts may be considered to help prevent retraction of the fascia and to avoid progression to a Grade 2 open abdomen.

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Grade 2a: Clean open abdomen developing adherence and/or fixity Where adhesions have developed between the intestines and the abdominal wall and/or the fascia has retracted laterally, delayed primary fascial closure becomes difficult to achieve. Treatment should aim to minimize the retraction of the fascial edges and prevent further deterioration, with the goal of converting the patient to a Grade 1a open abdomen. After addressing any complications or fixity, the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy may be applied. Insertion of the visceral protective layer deep into the paracolic gutters is essential to completely separate the viscera from contact with the abdominal wall and to ensure drainage of exudate. Formation of adhesions of the viscera to the abdominal wall may reduce the likelihood of fascial reapproximation and increase the risk of fistual development, common complications in patients with exposed viscera. When adhesions are dense and difficult to divide, caution and good clinical judgement are vital to avoid damage to the bowel and an increased risk of fistula formation.

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2. TOTAL MANAGEMENT OF THE OPEN ABDOMEN

Grade 2b: Contaminated open abdomen developing adherence and/or fixity In patients where source control has not yet been achieved and where adhesions and/or fixity may preclude subsequent fascial closure, the primary aim is to control the contamination and to convert the patient to a Grade 2a with no further deterioration. A KCI system for active abdominal therapy can be applied as above (see Grade 2a).

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Grade 3: Open abdomen complicated by fistula formation The development of an enteroatmospheric/enterocutaneous fistula represents a major deterioration that significantly impacts on management. The bowel is not always fixed in this situation and some patients may be converted to a Grade 1a if managed early and correctly. This requires attention to sepsis, anatomy, nutrition and the timing of surgery. The primary aim is to control the fistula and prevent loss of abdominal domain, lateralization of the fascia or damage to the skin. If the fistula can be controlled, the patient may be successfully moved into a Grade 1 or 2, with subsequent delayed fascial closure. However, in practice, conversion from a Grade 3 to a Grade 1 is difficult and is not achieved in many individuals. Prevention of adhesions and/or fixity is of great importance to avoid progression to a fixed and frozen abdomen (Grade 4).

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There are limited reports on the use of standard V.A.C.® Therapy in these patients, but it is not recommended as a first-line treatment for fistula and should be used only by healthcare professionals with appropriate training and expertise. The aim is to manage and isolate the fistula effluent to prevent continual contamination of the abdomen.

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Grade 4: Frozen open abdomen with adherent/fixed bowel, unable to close surgically, with or without fistula Patients with a frozen abdomen, with or without fistula, need a very different management approach compared to other grades and will require referral to a specialist center. In patients with a Grade 4 open abdomen with a fistula the primary aim is to control the fistula and optimize the patient’s physiology, protecting the skin and fascia and preventing sepsis.

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Simple closure of the skin over the granulated wound bed/viscera or planned ventral hernia may be possible. These strategies allow for early patient discharge, but are associated with subsequent herniation and requirement for further reconstructive surgery. In specialist centers, definitive reconstruction for Grade 4 often entails staged closure to manage the fistulating bowel and to achieve temporary fascial closure using an absorbable mesh. The risk of hernia is high and therefore the need for subsequent surgical procedures is common.

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2. TOTAL MANAGEMENT OF THE OPEN ABDOMEN

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It has been reported that techniques such as component separation18 or other progressive fascial closure methods may help surgeons achieve fascial or functional abdominal closure. Biologic materials such as Alloderm® Regenerative Tissue Matrix or Strattice™ Reconstructive Tissue Matrix may be considered to support fascial closure by reinforcing the primary midline repair. This allows for a single stage repair without the need for a planned repair procedure 6 - 18 months later. Alternatively, tissue matrix may be considered as a bridge to abdominal closure if delayed primary fascial closure is not possible. However, it is important to continue to follow the same philosophy with the goal of re-approximating the midline and taking measures to minimize the fascial defect as much as possible prior to definitive closure 19.

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INITIAL APPLICATION AND DRESSING CHANGES Prior to application the surgeon or practitioner should check for necrosis, ischemia, contamination or infection and adhesions. In addition, the integrity of anastomoses should be protected and the IAP measured and recorded if appropriate. The initial application of the ABThera™ System for active abdominal therapy and subsequent dressing changes should be performed under aseptic conditions in the operating theater or ICU, depending on the individual facilities.

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The recommended interval between dressing changes is 24 - 72 hours. More frequent dressing changes may be indicated in the presence of infection or abdominal contamination. The actual timing of dressing changes may also vary depending on the patient’s clinical status. Individual experience and patient needs will ultimately guide practice.

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At each dressing change, the surgeon needs to re-evaluate whether the abdomen can be closed and, if not, whether treatment should be modified. At all times a strategy for discontinuing therapy or finally closing the abdomen should be considered. TIMING OF DEFINITIVE CLOSURE The timing of closure will be determined by the surgeon’s perception and clinical experience, together with various structural and physiological factors. In addition, a number of parameters including hypothermia, acidosis, lactemia, coagulopathies and IAH may predict the development of ACS and contradict abdominal closure. However, these are usually of greater concern in the early treatment phase of the open abdomen and not at the time of late closure. Monitoring of these parameters and appropriate treatment strategies may lead to reduced mortality rates. For criteria of when to close the abdomen, see Principles for Managing the Open Abdomen, page 4.

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2. TOTAL MANAGEMENT OF THE OPEN ABDOMEN

It is important to have a clear strategy of therapy and to close the abdomen as early as possible to minimize the risk of complications.

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DISCONTINUING THERAPY Although most patients will benefit from abdominal closure, this is not the primary goal for a small percentage of patients for whom management of the open abdomen is an ongoing process. Abdominal therapy may be discontinued where it is felt that continuing to strive for delayed primary fascial closure is counterproductive (e.g. in the elderly individual with cardiopulmonary comorbidities who cannot tolerate repeated general anesthesia).

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Conversely, it may be useful to continue with the dressings where this makes the patient more comfortable or easier to manage. For example, it may be possible for patients requiring prolonged treatment with an open abdomen to be nursed outside the ICU, allowing patients to ambulate and receive enteral feeding between dressing changes.

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

Prior to application please refer to the important safety information for the ABThera™ Open Abdomen Negative Pressure Therapy System located in Appendix 1. Also, for detailed instructions for use, please refer to the ABThera™ Open Abdomen Negative Pressure Therapy System instructions for use included with each ABThera™ dressing and therapy unit.

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USING THE ABTHERA™ OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM FOR ACTIVE ABDOMINAL THERAPY The decision to use the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy should be made by the lead clinician. Patients should be assessed on an individual basis following a comprehensive examination in the operating theater. Consider applying dressing at the time of surgery or as early as possible. Complications such as adhesions and fistula development are common in patients with exposed viscera. Management of the open abdomen is complex. The ABThera™ NPT System for active abdominal therapy should be used only by healthcare professionals who have received specific training and who will continue to gain expertise through regular clinical practice.

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The first application of the ABThera™ Open Abdomen Negative Pressure System for active abdominal therapy in the acute situation should take place in the operating room under general anesthesia. Subsequent dressing changes usually take approximately 15 - 20 minutes when performed by an experienced surgeon or practitioner. Correct application is critical for optimal results. Specific indications, contraindications, warnings, precautions and safety information exists for the ABThera™ Open Abdomen Negative Pressure Therapy System for active abdominal therapy. Read instructions for use accompanying the device prior to application. WOUND PREPARATION WARNING: Review all ABThera™ Negative Pressure Therapy System Safety Information before beginning wound preparation. Ensure adequate hemostasis has been achieved prior to dressing placement (refer to "Bleeding" section under WARNINGS). 1. Sharp edges or bone fragments must be eliminated from wound area or covered (refer to "Bleeding" section under WARNINGS). 2. Irrigate abdominal wound and cleanse periwound skin as indicated. 3. Clean and dry periwound tissue; consider use of a skin preparation product to protect periwound skin. Do not allow foam to overlap onto intact skin. Protect fragile/friable periwound skin with additional drape, hydrocolloid, or other transparent film.

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

ABTHERA™ VISCERAL PROTECTIVE LAYER (VPL) APPLICATION

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Sizing the Visceral Protective Layer can be achieved by folding or cutting. WARNING: The foam in the visceral protective layer is encapsulated for patient safety. Protect vital structures with Open Abdomen visceral protective layer at all times during therapy. Never place exposed foam material directly in contact with exposed bowel, organs, blood vessels or nerves. NOTE: The visceral protective layer is fenestrated to allow for active fluid removal when negative pressure is applied and is designed to allow application of this layer directly over omentum or exposed internal organs. 1. Remove contents from inner pouch and unfold the visceral Fig. 1 protective layer in a sterile field. Either side of the visceral protective layer may be placed on the omentum or viscera. 2. Gently place visceral protective layer over the open abdominal cavity (Fig. 2). 3. Determine the orientation of the dressing for the specific application. If visceral protective layer will be placed around Fig. 2 tubes, drains or the falciform ligament, cut only between the foam extensions (Fig. 1). (Do not cut near or through foam extensions). Orient the visceral protective layer accordingly before cutting.

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FOLDING VISCERAL PROTECTIVE LAYER TO SIZE 1. Hold dressing by the edge and slightly lift. Then slowly lower dressing into the paracolic gutter, while using the other hand to gently and evenly work the dressing down. (Fig. 3). Fold any excess visceral protective layer up and over onto itself. 2. Continue placing visceral protective layer between abdominal wall and internal organs (Fig. 4) throughout the abdominal compartment. The goal is to ensure full coverage of all viscera.

Fig. 3

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Fig. 4

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

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CUTTING VISCERAL PROTECTIVE LAYER TO SIZE

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1. Cut visceral protective layer away from wound, through center of large foam squares using sterile scissors (Fig. 5A). Do not cut through narrow connecting tabs between the large foam squares. 2. Pinch the remaining half of the foam square and its connecting tab and pull. The foam and tab will separate at the next square (Fig. 5B). This will ensure that edges of visceral protective layer cover exposed foam edge (Fig. 5C), and foam cannot contact organs (see WARNING in previous section). NOTE: Document number of foam extensions removed and that each piece has been properly disposed of away from wound cavity. CAUTION: Do not tear the foam over the wound, as fragments may fall into the wound. Rub or trim foam away from wound, removing any fragments to ensure loose particles will not fall into or be left in the wound upon dressing removal.

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PERFORATED FOAM APPLICATION 1. Tear the perforated foam to the needed size along perforations. The foam should fit directly over the visceral protective layer while still being in contact with all wound edges. Do not allow foam to contact intact skin. One or both pieces of the provided perforated foam can be used, depending on the wound profile. 2. Gently place perforated foam into wound cavity over the visceral protective layer (Fig. 6). Ensure that perforated foam does not go below the level of the abdominal incision or wound. Do not force foam into any area of the wound. NOTE: Ensure foam-to-foam contact for even distribution of negative pressure. Fig. 6 NOTE: Always note the total number of pieces of foam used and document on the drape and in the patient's chart.

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

DRAPE APPLICATION Fig. 7

Fig. 9

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Fig. 10

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1. Holding the open abdomen drape, partially pull back one side of layer 1 to expose adhesive (Fig. 7). Be sure to hold layer 1 flap back, to prevent re-adherence to drape. 2. Place the drape adhesive-side down to cover foam and intact skin, ensuring drape covers at least a 8 - 10cm border of intact periwound tissue (Fig. 8). Use any excess drape to seal difficult areas, if needed. NOTE: To avoid trauma to the periwound skin, do not pull or stretch the drape over the foam dressing. Minimize wrinkles, as they may be a source of negative pressure leaks (refer to PRECAUTIONS, "Protect Periwound Skin" section). 3. Remove remaining tab 1 backing material and pat around drape to ensure an occlusive seal. 4. Remove green-striped stabilization layer 2 (Fig. 9). 5. Remove perforated blue handling tabs from drape (Fig. 10). NOTE: When using multiple pieces of drape, ensure that the edges of the drape overlap in order to achieve a seal (Fig. 11).

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

TUBING SET/INTERFACE PAD APPLICATION Fig. 15

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NOTE: Do not cut off the interface pad or insert the tubing into the foam dressing. This may occlude the tubing and cause the therapy unit to alarm and could injure underlying viscera. 1. Choose interface pad application site. Give particular consideration to fluid flow and tubing position to allow for optimal flow and avoiding placement over bony protuberances or within creases in the tissue. 2. Pinch drape and cut a 2.5cm hole (not a slit) through the drape (Fig. 12). It is not necessary to cut into the foam. NOTE: Cut a hole rather than a slit, as a slit may self-seal during therapy. 3. Apply interface pad, which has a central disc and a surrounding outer adhesive skirt. • Gently remove both backing layers 1 and 2 to expose adhesive (Fig. 13). • Place interface pad opening in central disc directly over hole in drape (Fig.14). • Apply gentle pressure on the central disc and outer skirt to ensure complete adhesion of the interface pad. 4. Pull back on blue tab to remove pad stabilization layer (Fig. 15). ABThera™ Dressing application is complete. See the PREPARATION FOR USE section.

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DRESSING REMOVAL Remove and discard previous dressing per institution protocol. Completely inspect wound, including paracolic gutters, to ensure all pieces of dressing components have been removed. If intra-abdominal packing material is present, packing material may be drier than anticipated. Evaluate packing material prior to removal and rehydrate if necessary to prevent adherence or damage to adjacent structures. WARNING: Refer to "Dressing Removal" section under WARNINGS. DRESSING CHANGES Dressing changes should occur every 24 - 72 hours, or more frequently based upon a continuing evaluation of wound condition and patient presentation. Consider more frequent dressing changes in the presence of infection or abdominal contamination. WARNING: Refer to "Application Setting" section under WARNINGS. Whenever the open abdomen dressing is changed, always replace all ABThera™ Dressing components with components from an unopened sterile package.

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

ABTHERA™ OPEN ABDOMEN NEGATIVE PRESSURE THERAPY UNIT Vacuum Port

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Power Cord Connector

User Interface

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USER INTERFACE Power and Therpy On/Off Button

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Blockage Alarm Leak Alarm

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1000 (CC/ML) CANISTER Canister used with the ABThera™ Open Abdomen Negative Pressure Therapy Unit is a single-use, latex free, non-sterile, 1000 (cc/mL) clear container with graduated markings at 100 (cc/mL) increments up to 800 (cc/mL). NOTE: Never reuse a canister.

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3. APPLICATION OF THE ABTHERA™ SYSTEM FOR ACTIVE ABDOMINAL THERAPY

PREPARATION FOR USE CONNECT TUBING SET/INTERFACE PAD TO CANISTER NOTE: Tubing Set is not compatible with hospital vacuum sources. 1. Place canister lid onto canister. 2. Place canister into therapy unit ensuring graduated markings on the canister can be viewed. 3. Attach tubing set to canister lid; see picture and steps 1-5 below.

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1. Slide tubing set onto canister patient port - 1. 2. Push tubing set down onto the canister vacuum port - 2. 3. Plug tubing set into connector port; the release latch on the connector port must be in the down position "A" before tubing is plugged in - 3 A & B. A click will indicate proper connection. Push release latch down to unplug tubing set. 4. Ensure tubing clamp is open - 4. 5. Ensure canister access port cap is securely in place - 5. Canister’s access port is for adding a gel to solidify contents (not provided by KCI).

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